Kornimate/medical-research-clean huggingface dataset:
study using pregnenolone to treat bipolar depression

Conditions: Bipolar Disorder; Major Depressive Disorder

Summary: primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. also the study will explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.

determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms than placebo in persons with bipolar depression (bpd), depressed phase. in our pilot study, pregnenolone showed a strong signal on depression scores. secondary 1. determine if pregnenolone supplementation is associated with greater improvement in anxiety symptoms in persons with bpd, depressed phase. data from prior studies suggests that pregnenolone may decrease symptoms of anxiety. anxiety is a common and clinically important feature of bpd. therefore, we will examine anxiety symptoms in this trial. 2. determine if pregnenolone supplementation is associated with improvement in manic symptoms as compared to placebo in persons with bpd, depressed phase. our pilot study suggested that pregnenolone may be associated with improvement in manic symptoms. although the current study targets bipolar depression we will also examine manic symptoms.

Eligibility criteria:
inclusion criteria: * men and women of all races age 18-75 years * diagnosis of bipolar i, ii or not otherwise specified (nos) disorders currently meeting criteria for a major depressive episode * english speaking exclusion criteria: * active suicidal ideation with plan and intent * treatment resistant depression * vulnerable population (i.e. pregnant, cognitively impaired, incarcerated) * severe or life threatening medical condition * history of allergic reaction or side effects with prior pregnenolone use * current substance use disorder defined as meeting criteria for abuse or dependence based on the structured clinical interview for the diagnostic and statistical manual (dsm)(scid) interview and self-reported use within the past 3 months or a positive baseline urine drug screen * removal or addition of concomitant psychiatric medications within 10 days prior to randomization * current warfarin therapy * current use of oral contraceptives * current hormone replacement therapy * history of heart disease or arrhythmias * current (past 7 days) systemic
sweet scents to sweet dreams

Conditions: Sleep Disturbance; Mental Health Issue

Summary: the purpose of this study is to determine the effect of herbal pillows on sleep and quality of life in a healthy population using actigraphy, validated questionnaires and daily diary logs. the goal of this study is to improve sleep and quality of life using herbal and ayurveda/holistic-based botanical pillows.


Eligibility criteria:
inclusion criteria: * you must be at least 18 years of age. * you must be willing to adhere to a sleep hygiene protocol (e.g., 10pm-midnight-6-8am) for 2 weeks without interruption in the comfort of your home. * you must be willing to wear a watch that monitors your sleep and light as well as a sleep mask for two consecutive weeks. * during the testing period, you must be willing to refrain from alcohol and anything that can affect mood and sleep. * you must allow for the placement of an herbal pillow next to your head while sleeping for one week during testing. * you must be willing to fill out short sleep logs during the 2 weeks of testing. * you must also be willing to come to the study location on 3 occasions over a 2 week period. exclusion criteria: * males or females with any condition that prevents adequate inhalation of botanical pillows \[e.g., chronic obstructive pulmonary disease (copd), use of a continuous positive airway pressure (cpap), deviated septum, etc\]. * males or females on mood altering substances prescription (e.g., anti-depressants, anxiolytics, ritalin, adderall, anti-convulsants; opioids, etc), non-prescription/over-the-counter (otc) drugs/herbal/natural products \[(e.g., tetrahydrocannabinol (thc)-containing compounds, melatonin, st. john's wort, lavender capsules, essential oils, perfume-containing products, etc\]. * any environmental, physical condition or pathology that can significantly impact on sleep and prevent an approximate 10pm-midnight-6-8am sleep rhythm (e.g., shift work, studying/exams, rotations, insomnia, new parents, nocturia, restless leg syndrome, chronic pain, etc). * any medications that can influence sleep \[(e.g., use of beta blockers; anti-histamines; dexamethasone; angiotensin converting enzyme inhibitor (acei); nicotine products, alpha blockers\] * chemical sensitivities * allergies * pregnancy.
a study of high-intensity strength training and thoracic aorta dilatation

Conditions: Thoracic Aorta Dilatation

Summary: the purpose of this study is to describe the prevalence of thoracic aorta dilatation among a group of older (age \> 35 years), experienced weightlifters (\>5 years of weightlifting experience). the secondary aim of this study is to report the prevalence of thoracic aorta dilatation among 3 different groups of weightlifters (body builders, cross-fit athletes, and power lifters).


Eligibility criteria:
inclusion criteria: * age ≥ 35 * ≥5 years of weightlifting experience exclusion criteria: * age \< 35 * \< 5 years of weightlifting experience * personal history of thoracic aorta dilatation/aneurysm/dissection
study of sunitinib with s-1 and cisplatin for gastric cancer

Conditions: Stomach Neoplasms

Summary: to assess the maximal tolerated dose (mtd) and overall safety of sunitinib when administered in combination with s-1 and cisplatin in patients with advanced/metastatic gastric cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of gastric cancer * chemonaive patients * adequate organ function exclusion criteria: * patients who meet the contra-indications of s-1 and cisplatin. * prior chemotherapy failure patients

Keywords: chemotherapy combination
trial of anti-psma designer t cells in advanced prostate cancer after non-myeloablative conditioning

Conditions: Prostate Cancer

Summary: this study tests the safety and tolerability of autologous anti-psma gene-modified t cells (designer t cells) in hormone refractory prostate cancer.

the study creates autologous gene-modified t cells against prostate specific membrane antigen (psma, unrelated to psa) (designer t cells) by ex vivo modification of patient t cells. t cells are collected by leukopheresis, transported to the rwmc cgmp cell manipulation core and transduced with retrovirus containing a chimeric antigen receptor (car) that is expressed on the modified cells. this car links specificity of an antibody against psma with signaling domains of the t cell and redirects the recognition of the t cells to engage and kill prostate cancer cells anywhere in the body. these are administered at a dose of 10\^10 with randomization to either low or moderate interleukin 2 given by ci (continuous infusion) for one month following the t cell infusion. subsequent subjects will receive 10\^11 cells with interleukin 2 at either low or moderate dose, in a non randomized manner, depending upon the outcome of the prior cohort. prior to t cell infusion, all subjects will receive non-myeloablative (nma) conditioning. this conditioning creates a "space" in the blood and marrow for engraftment of the infused cells to maintain of high level of anti-tumor effector t cells in the body. each patient is treated with a single dose of t cells, without repeat dosing. patients are followed for toxicity and response and pharmacokinetics-pharmacodynamics of the infused t cells. patients are on-study for one-month after their t cell dose.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of prostate cancer 2. elevated psa 3. life expectancy \> 4 months 4. performance status 0-1 5. anc 1.0 6. platelets \> 100,000 7. hemoglobin \> 8.0 8. creatinine \< 1.5mg/dl 9. direct bilirubin \< 1.5 mg/dl 10. no evidence of chf, cad, cardiac arrhythmias, a-fib, a flutter, myocardial infarction. 11. no serious, symptomatic obstructive or emphysematous lung disease 12. no asthma requiring iv medication during last 12 months, no serious lung disease associated with dyspnea at normal activity levels, or at rest due to any cause, including cancer metastasis and pleural effusion 13. patients must have a biopsy able tumor, and be willing to undergo biopsy (group 3 only) 14. patient is at least 18 years of age. exclusion criteria: 1. serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease based on history, labs or physical exam 2. active clinical disease caused by cmv, hepatitis b, or c, hiv, tb 3. cytotoxic and/or radiation therapy during last 4 weeks prior to entry 4. any concurrent malignancies 5. patient requires systemic steroids 6. patient has participated in prior investigational therapy 7. patient has prior exposure to mouse antibody 8. patient has had irradiation to whole pelvis or \>25% marrow

Keywords: prostate cancer t cells gene transfer
physical function in critical care (pacific)

Conditions: Intensive Care (ICU) Myopathy

Summary: impairment in physical function is a significant problem for survivors of critical illness. there is a growing urgency to develop a core set of outcome measures, which can be adopted in clinical and research practice to evaluate efficacy in response to interventions such as rehabilitation. phase 1: development of a new outcome measure. this study aims to examine the development of a single outcome measure which may be able to be utilised across the continuum of recovery of critical illness in the evaluation of physical function. the study will involve examination of two common physical function measures - the physical function in intensive care test scored (pfit-s) and de morton mobility index (demmi) and the development of a new measure based on rasch principles which may be able to capture physical functioning changes in individuals with critical illness. aims: (1) to determine the clinical utility of two physical function measures (demmi and pfit-s) when used in isolation across the hospital admission; and (2) to transform the (15-item) demmi and (4-item) pfit-s into a single measure to evaluate function in intensive care survivors using rasch analytical principles. phase 2: measurement properties of the pacific physical function outcome measure in an independent validation sample.

consecutive eligible patients will be recruited into the study. phase 1: two outcome measures - pfit-s and demmi will be performed within 24 hour period. order of testing will be randomised to minimise testing bias. time-points of assessment are: awakening, icu discharge and hospital discharge. weekly measures will also be performed if required in icu and/or ward settings for up to a maximum of 30 days in each setting. the measurement properties of the individual tools pfit-s and demmi will be examined (e.g. validity, responsiveness). phase 2: based on the findings in phase 1 a new single outcome measure will be developed. in the second phase examination of the measurement properties of the tool will be undertaken including (reliability, validity, responsiveness).

Eligibility criteria:
inclusion criteria: * adults \> 18 years of age * mechanically ventilated \> 48 hours * premorbid able to ambulate at least 10m independently prior to icu admission (+/- gait aid) exclusion criteria: * premorbid physical or cognitive impairment which would prevent ability to perform functional measures * new neurological impairment such as stroke or spinal cord injury * trauma or orthopaedic injury requiring period of immobilization or non weight bearing status * traumatic brain injury with focal neurology

Keywords: physical function critical care
online interventions for gamblers with and without co-occurring mental health concerns

Conditions: Gambling; Depression; Anxiety

Summary: comorbidity between problem gambling and mental health concerns such as anxiety and depression is common. further, the treatment needs of people with co-occurring gambling and mental health concerns may be different from those of problem gamblers who do not have a co-occurring mental health concern. the present study is a two-arm, double blinded, parallel group randomized controlled trial (rct) that will evaluate whether there is a benefit to providing access to mental health internet interventions (g+mh intervention) in addition to an internet intervention for problem gambling (g-only intervention) in participants with gambling problems who do or do not have co-occurring mental health concerns.

people with gambling concerns will be recruited using targeted advertisements. potential participants will be screened using an online survey to identify participants meeting criteria for problem gambling. as part of the baseline screening process, measures of current depression and anxiety will be assessed. eligible participants agreeing to take part in the study will be randomized to one of two versions of an online intervention for gamblers - an intervention that just targets gambling issues (g-only) versus one that contains interventions for anxiety and depression in addition to an intervention for gamblers (g+mh). it is predicted that problem gamblers who do not have co-occurring mental health concerns will display no significant difference between intervention conditions at a six-month follow-up. however, for those with co-occurring mental health concerns, it is predicted that participants receiving access to g+mh website will display significantly reduced gambling outcomes at six-month follow-up as compared to those provided with g-only website.

Eligibility criteria:
inclusion criteria: * 18 years of age or over * score of 3 or greater on the problem gambling severity index of the canadian problem gambling index (pgsi- cpgi) exclusion criteria: * none
effect of weight loss diet and pumpkin seed flour consumption on obese women

Conditions: Obesity

Summary: this study aimed to evaluate the effect of weight loss diet combined with pumpkin seed flour consumption on diet improvement, weight loss, and glucose and cholesterol reduction in obese.


Eligibility criteria:
inclusion criteria: * age from 20 to 59 years old. * body mass index above 30 kg/m2 exclusion criteria: * diabetic * loss weight before the research * consumption of vitamins or dietary supplement. * pregnancy

Keywords: obesity cardiovascular risk factors pumpkin seed diet quality
intranasal desmopressin vs iv ketorolac in renal colic pain control

Conditions: Renal Colic

Summary: the aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal desmopressin in renal colic patients pain control.

40 renal colic patients have been divided into 2 groups randomly, one group has been received 30mg intravenous ketorolac and 4 puffs nasal normal saline while other has been received 40 micrograms nasal desmopressin and 1cc intravenous normal saline. pain score before drug administration,also 10, 30 and 60 minutes after drug administration has been measured bye visual analogue scale ( vas ).

Eligibility criteria:
inclusion criteria: * renal colic patients exclusion criteria: * history of hypertension and cardiac disease * pregnant patients * use of analgesic within 4 hours before intervention
surgical bleeding control of extra-corporeal circulation (ecc) by vacuum devices

Conditions: Bleeding

Summary: the purpose of this study is to show that the vacuum control surgical bleeding helps stop bleeding extramd (md: medical device) at the orifice of the retrograde cannulation during a heart with extra-corporeal circulation (ecc),


Eligibility criteria:
inclusion criteria: * more or equal than 18 years old * patient affiliated to social security or similarly regime * patient sent to hospital for cardiac surgery requiring ecc exclusion criteria: * pregnant women and lactating mothers * ward of court or under guardianship * adult unable to express their consent * person deprived of freedom by judicial or administrative decision * person hospitalized without their consent * person under legal protection * person participating in another clinical study

Keywords: cardiac surgery requiring ecc
efficacy of silodosin in the treatment of symptomatic benign prostatic hyperplasia (bph)

Conditions: Benign Prostatic Hyperplasia

Summary: in this study the investigators had evaluated the effectiveness silodosin (8 mg daily orally) in benign prostatic hyperplasia in comparison to tamsulosin (0.4 mg daily orally) in a randomized controlled trial design. study population would be patients attending urology opd of bsmmu hospital, dhaka. target sample size will be 136 evaluable patients in each group (assuming dropout rate 20%), suffering from benign prostatic hyperplasia .subjects would be observed for 1 week without any drug. at the end of 1 week, they would be randomly allocated to silodosin or tamsulosin and treatment continued for 12 weeks. interim follow-up visits would be at 1,4 and 12 weeks. usg confirmation of bph would be required for recruitment. effectiveness of the drugs would be assessed by international prostate symptom score, a quality of life (qol) assessment done by a 7-point scale. prostate weight/volume determination by usg, change in post voidal residual urine (pvr) by usg and changes in peak urine flow rate by uroflowmetry. safety would be assessed by following up vital signs, treatment emergent adverse events and routine laboratory tests for drug safety.

benign prostatic hyperplasia (bph) is the most common cause of lower urinary tract symptoms in elderly men. selective α1-adrenergic antagonists are now ﬁrst-line drugs in the medical management of bph. this hospital based randomized controlled clinical study designed to evaluate the efficacy of the new α1-blocker silodosin in the treatment of symptomatic benign prostatic hyperplasia (bph).ambulatory patients of age between 50 to 70 years, who were diagnosed as benign prostatic hyperplasia, were divided into two groups after fulfilling selection criteria. after informed consent \& random sampling by lottery, silodosin 8 mg was given to group a (study) \& tamsulosin 0.4 mg was given to group b (control). total 149 patients were enrolled in this study but 8 patients were lost during follow up. hence 141 patients completed the study, during the period of june 2017 to august 2018.

Eligibility criteria:
inclusion criteria: * ambulatory male patients between 50 to 70 years and had diagnosis of lower urinary tract symptoms associated with benign prostatic hyperplasia (bph) * international prostate symptoms score (ipss)≥ 8 * peak urinary flow rate (qmax)\<15ml/sec for a voided volume of 150 ml or more * post voidal residual urine volume ≥ 50 ml (by transabdominal ultrasonogram) * volume of prostate determine by transabdominal ultrasonogram ≥ 30 gm exclusion criteria: * history of prostate cancer/raised psa\>4 ng/ml * previous prostate surgery /periurethral surgery. * patient undergone surgery to the bladder neck/bladder neck contracture. * urethral stricture * history of luts not due to benign prostatic hyperplasia (bph). * postvoid residual urine volume of \>150ml * bladder stone * active urinary tract infection which might affect micturition * large intravesical protrusion \> 2 cm * known hypersensitivity or history of active substance abuse
biologic therapy for generalized pustular psoriasis

Conditions: Generalized Pustular Psoriasis

Summary: the investigators aim to compare the efficacy and safety of secukinumab and ustekinumab in patients with generalized pustular psoriasis (gpp), and to explore the impact of genetic mutation types on clinical efficacy. the main questions the study aims to answer are: is there a difference in the effectiveness of secukinumab and ustekinumab in the treatment of gpp? how is the safety of secukinumab and ustekinumab in the treatment of gpp? does the type of genetic mutation in gpp patients affect the efficacy of secukinumab and ustekinumab? the investigators will compare patients treated with secukinumab to those treated with ustekinumab to see the difference in the effectiveness of the two drugs in treating gpp. participants will: the investigators conducted a 48-week follow-up study on 65 participants who were admitted to the dermatology department of the first affiliated hospital of fujian medical university for gpp from july 2019 to december 2022. all participants underwent saliva-based genetic testing. efficacy analyses were performed based on the scores of generalized pustular psoriasis area and severity index (gppasi) and generalized pustular psoriasis physician global assessment (gppga) at week 0, 2, 4, 12, 24, and 48. participants were also asked to report all adverse events (aes) during follow-up.


Eligibility criteria:
inclusion criteria: 1. patients meet the diagnostic criteria for gpp. 2. patients had an average gppga score of 3 or higher (moderate to severe disease). 3. patients had discontinued the treatment with non-biologic agents before they started the treatment with ustekinumab/secukinumab. exclusion criteria: 1. pregnant and lactating patients. 2. patients with malignant tumors. 3. patients with a history of multiple drug allergies or a severe allergic constitution. 4. contraindications for ustekinumab/secukinumab, including active tuberculosis, active hepatitis b, hepatitis c, or inflammatory bowel disease. patients who were severely immunocompromised.

Keywords: secukinumab ustekinumab clinical efficacy generalized pustular psoriasis safety gene mutations